comparative study of patterns of immune response to covid 19 vaccination

Conditions: Immune Response to Covid 19 Vaccination

Summary: an effective vaccine stands as the most effective way for controlling the covid 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . t cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent sars-cov1 patients which needs to be tested in sars -cov2 vaccine efficacy studies alongside with the sustainability of humoral and cellular immune responses . clinically , immunocompromised patients face drastic outcome of infections , which led the advisory committee on immunization practices (acip) - usa -and the joint committee on vaccination and immunisation (jcvi) -uk- recommend covid-19 vaccination of immunocompromised , the who strategic advisory group of experts on immunization (sage), recommended that the three vaccines(pfizer ,moderna and astra zeneca) can be used for individuals with high-risk comorbidities . nevertheless, there is an unmet research need concerning the immune response towards covid 19 vaccination in this population . based on the previous work of our team in designing b and t cell epitopes distributed over the s protein , we will study the immune response in the available vaccines in egypt.

this proposed project is a joint collaboration between the national research center(nrc) , hematology treatment unit of the holding company for biological products and vaccines (vacsera) and theodor bilharz research institute . after a 1 month period of preparation , enrollment will start at month 2 (m2) over a 2 months enrollment window, where persons from 18-70 years old , of both sexes , having their first vaccination dose no more than 3 weeks of any of the available vaccines in egypt will be enrolled into the project after signing an informed consent . healthy persons not suffering from any systemic diseases will be enrolled from theodor bilharz vaccination center , and the medical researches center of excellence ( mrce) at the nrc from the nrc vaccinated staff , while splenectomised b thalassemia patients will be enrolled from the hematology treatment unit at vacsera . first visit will be performed 3 weeks post the first vaccination dose , while the second visit will be performed 3 weeks post the second vaccination dose , and the third visit will be performed 3 months post the second vaccination dose where ( 5 ) ml of blood will be withdrawn at each visit for the determination of the primary immune response at the first 2 visits and the sustainability of the immune response at the third visit . enrolled persons will be instructed to contact the project logistics administrator upon experiencing any suspicious symptom of covid 19 infection ( fever- loss of taste and/or smell - myalgia - malaise - headache - diarrhea ) who will arrange for an additional visit where a pcr test for covid 19 will be performed for the determination of breakthrough infections , and if positive this will be considered a primary end point and an additional ( 5) ml of blood will be withdrawn for testing for the immune status .

Eligibility criteria:
inclusion criteria: 1. both sexes. 2. 3 weeks post scheduled first vaccination dose 3. healthy group not suffering from any systemic diseases. 4. b thalassemia major splenectomized group 5. signing an informed consent . exclusion criteria: 1- malignancy of whatever nature. 2- systemic diseases apart from b thalassemia for the b thalassemia group. 3- previous infection with covid 19 . 4- refusal to sign the informed consent . -